Events

Retiro De Equipo (Recall) de NOVA Lite ANA KSL Kit

Según U.S. Food and Drug Administration, este evento ( retiro de equipo (recall) ) involucró a un dispositivo médico en United States que fue producido por Inova Diagnostics Incorporated.

¿Qué es esto?

Una corrección al equipo o acción de retiro tomada por el fabricante para abordar un problema con un dispositivo médico. Los retiros (recalls) ocurren cuando un dispositivo médico está defectuoso, cuando puede poner en riesgo la salud, o cuando simultáneamente está defectuoso y puede poner en riesgo la salud.

Más información acerca de la data acá
  • Tipo de evento
    Recall
  • ID del evento
    60219
  • Clase de Riesgo del Evento
    Class 3
  • Número del evento
    Z-0280-2012
  • Fecha de publicación del evento
    2011-11-23
  • Estado del evento
    Terminated
  • País del evento
    United States
  • Fecha de finalización del evento
    2012-04-04
  • Fuente del evento
    USFDA
  • URL de la fuente del evento
    https://www.accessdata.fda.gov/scripts/cdrh/cfdocs/cfres/res.cfm?id=104801
  • Notas / Alertas
    U.S. data is current through June 2018. All of the data comes from the U.S. Food and Drug Administration, except for the category Manufacturer Parent Company.
    The Parent Company was added by ICIJ.
    The parent company information is based on 2017 public records.
  • Notas adicionales en la data
    in vitro diagnostic - Product Code DHN
  • Causa
    The nova lite ana ksl kit label has the wrong fill volume for the ifa system negative control (p/n 508186) with 1ml. the component in the kit is correctly labeled and filled with the 0.5ml fill volume.
  • Acción
    On 9/26/11, Inova Diagnostics forwarded an Urgent Advisory Notice and Product Advisory Notice Fax Back Form to all their customers who purchased the Nova Lite Ana KSL, Product Code: 708390. The letter provides the customers with an explanation of the problem identified and an action to be taken. Customers were instructed to complete the attached fax back form indicating how many of these kits they have in their inventory, quantity destroyed, method of destruction and the quantity of kits that need to be replaced. Customers were also instructed to notify their customers of the advisory notice. Customers were instructed to contact Tana Keivens with any questions or comments at (858) 586-9900 ext 351.

Device

NOVA Lite ANA KSL Kit
  • Modelo / Serial
    070409, 070491, 170069, 17014E1, 170214E2, 170440
  • Clasificación del producto
    Immunology and Microbiology Devices
  • Clase de dispositivo
    2
  • ¿Implante?
    No
  • Distribución
    Worldwide distribution to: USA, Mexico, Kuwait, Uraguay, Romania, Italy, Philippines, India, Malaysia, Algeria, Czechoslovakia, Brazil, Colombia, Ireland, Korea, and Saudi Arabia.
  • Descripción del producto
    Inova Diagnostic Inc., NOVA Lite ANA KSL Kit || Part Number: 708390. in vitro diagnostic.
  • Manufacturer
    Inova Diagnostics Incorporated

Manufacturer

Inova Diagnostics Incorporated
  • Dirección del fabricante
    Inova Diagnostics Incorporated, 9900 Old Grove Rd, San Diego CA 92131-1638
  • Empresa matriz del fabricante (2017)
    Werfenlife Sa.
  • Source
    USFDA